University Health System

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation of the laboratory, review of the manufacturer's control package insert, and interview with the laboratory lead, the laboratory failed to label three of three control vials used for performing quality control on the Complete Blood Count (CBC) hematology analyzer with an open date and a corrected expiration date on the date of the survey (11.05.2025). The findings include: 1. Observation of the laboratory on 11.05.2025 at 9:50 a.m. revealed the Sysmex XS-1000i CBC analyzer (Serial Number 75474) used for patient testing, and three levels: low [lot 52580804], normal [lot 52580805], and high [lot 52580806] of e-CHECK (XS) Sysmex controls that were not labeled with an open date and corrected expiration date. 2. A review of the manufacturer's control package insert revealed the following: "Opened and recapped vials and vials whose caps have been pierced will retain stability for 14 days if stored at 2-8C." 3. An interview with the laboratory lead on 11.05.2025 at 09:55 a.m. confirmed the above survey findings. Word Key: C = degrees Celsius D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: . Based on observation of the laboratory, review of the Sysmex XS-1000i operator's manual, Sysmex calibration records, and staff interviews, the laboratory failed to verify calibration of the Sysmex XS-1000i Complete Blood Count (CBC) analyzer every six months as recommended by the manufacturer in 2024. The findings include: 1. An observation of the laboratory on 11.05.2025 at 9:50 a.m. revealed a Sysmex XS- 1000i CBC analyzer (Serial Number 75474), used for patient testing. 2. Review of the Sysmex XS-1000i operator's manual revealed the following statement: "The laboratory must verify calibration every six months or on an "as needed" basis to ensure accuracy of the system". 3. A review of the Sysmex calibration records revealed that the Sysmex calibration was verified in August 2023 and August 2024. The calibration verification, which was due in February 2024, was not performed, resulting in a 12-month period between calibrations. 4. An interview with the laboratory lead on 11.05.2025 at 12:30 p.m. and a follow-up electronic message on 11.10.2025 at 5:27 p.m. confirmed the above survey findings. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: . Based on review of the laboratory Proficiency Testing (PT) records, random patient test report review, and staff interviews, the laboratory director failed to ensure the laboratory was re-enrolled in a Health and Human Services (HHS) approved proficiency testing program for 2025 for the complete blood count (CBC) regulated analytes to include white blood cell (WBC), red blood cell (RBC), platelet (PLT), hemoglobin (Hgb), hematocrit (Hct), and automated WBC differential (WBC Diff). The findings include: 1. Review of the laboratory PT records revealed there was no documentation of participation for 2025 for the regulated analytes WBC, RBC, PLT, Hgb, Hct, and WBC Diff. 2. Review of patient test reports revealed patient reporting for CBC on 03.20.2025 (patient 0405097) and on 09.12.2025 (patient 1981765). 3. Interviews on 11.05.2025 at 08:40 a.m. with the laboratory lead and at 08:50 a.m. with the office manager confirmed the 2025 order for PT had not been submitted. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records and interview with the laboratory liaison, the laboratory director and testing person failed to sign one of three PT attestation statements in 2023. The findings include: 1. Review of the laboratory's proficiency testing records revealed the attestation statement for hematology 2023 event three was not signed by the laboratory director or testing personnel. 2. Interview with the laboratory liaison on 01.24.2024 at 12:45 p.m. confirmed the laboratory director and testing person failed to sign the attestation statement for one of three PT events in 2023. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of College of American Pathologists (CAP) proficiency testing (PT) records and interview with the laboratory liaison, the laboratory failed to return proficiency testing results to the proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- program before the due date resulting in a score of 0% for hematology 2022 Event 2. The findings include: 1. Observation of the laboratory on 01.24.2024 at 7:15 a.m. revealed a Sysmex XS-1000i (serial number 75474) hematology analyzer in use for complete blood count patient testing. 2. Review of hematology 2022 Event 2 CAP PT records revealed "exception code [40] Results for this kit were not received" and test scores of 0% for cell identification/differential, red blood cell count, hematocrit, hemoglobin, white blood cell count, and platelet count. 3. Interview with the laboratory liaison on 01.24.2024 at 12:45 p.m. confirmed the laboratory failed to return proficiency testing results to CAP for hematology 2022 Event 2 before the due date specified by the program resulting in a score of 0% for the testing event. Word Key: % = percent D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory records and interview with the laboratory liaison, the laboratory failed to retain Complete Blood Count (CBC) quality control (QC) records for two of seven lots reviewed in 2023. The findings include: 1. Observation of the laboratory on 01.24.2024 at 7:15 a.m. revealed a Sysmex XS-1000i (serial number 75474) hematology analyzer in use for CBC patient testing. 2. Review of QC records for the Sysmex XS-1000i CBC analyzer revealed no retention of Level 1, 2, and 3 quality control data for lots 3149 and 3205 to include daily QC performance as compared with expected ranges or daily quality control graphed on the Levy-Jennings plot. 3. Interview with the laboratory liaison on 01.24.2024 at 12:45 p.m. confirmed the above findings. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Citation One Based on review of the laboratory procedure manual, review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records, and phone interview with the office manager, the laboratory failed to follow its' own policy for review/evaluation of proficiency testing results for five of five events reviewed from 2022 and 2023. The findings include: 1.Review of the laboratory's policy titled "Quality Assurance" revealed the following under the section titled "Proficiency Testing": "We forward the results of our proficiency testing (PT) to the laboratory director within one week of the return from the PT program. The director will carefully evaluate any unacceptable, unsatisfactory, or unsuccessful proficiency testing result in an effort to identify the cause of the failure". 2.Review of the laboratory's CAP proficiency testing result records revealed no documentation of -- 2 of 3 -- laboratory director review/evaluation for five of five events (2022 events two and three and 2023 events one, two, and three) reviewed. 3.Phone interview with the office manager on 01.24.2024 at 2:15 p.m. confirmed the laboratory failed to follow its' own policy for review/evaluation of proficiency testing results for five of five events reviewed in 2022 and 2023. Citation Two Based on review of the laboratory's Proficiency Testing Policy, review of proficiency testing records, request for documented

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: ==================================== Review of 2018 Proficiency Testing (PT) records and interview with the laboratory supervisor determined the testing personnel and laboratory director/designee failed to sign attestation sheets. The findings include: 1. Review of 2018 PT records revealed attestation sheets were not signed by testing personnel or laboratory director/designee. 2. Interview with the laboratory supervisor at approximately 12:00 p.m. May 17, 2019 confirmed the 2018 Proficiency Testing attestation sheets were failed to be signed by testing personnel or laboratory director/designee. ===================================== D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: ==================================== Upon review of Complete Blood Count (CBC) quality control (QC) records for 2018 and interview with the laboratory supervisor, determined QC records had not been retained for lot number 8016, dates 1 /24/18 to 4/8/18. The findings include: 1. Upon review of CBC quality control records Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- for 2018, it was discovered that QC records for lot number 8016, dates 1/24/18 to 4/8 /18 were not available for review. 2. Interview with laboratory supervisor at approximately 12:00 p.m. May 17, 2019 confirmed that CBC quality control records, lot number 8016, for dates 1/24/18 to 4/8/18 were not available for review. ==================================== D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: ==================================== Based on review of five patient Complete Blood Count (CBC) reports for dates 1/28/19, 3/28/19, 11/28/18, 8/1/18 and 4/10/18 with no testing personnel identification and upon interview with the laboratory supervisor, determined the laboratory failed to document identity of testing personnel on CBC reports for 2018 and 2019. The findings include: 1. Review of five patient CBC reports for 1/28/19, 3/28/19, 11/28/18, 8/1/18 and 4/10/18 revealed no testing personnel identification. 2. Interview with laboratory supervisor at approximately 12:00 p.m. May 17, 2019 confirmed five patient reports reviewed for dates in 2018 and 2019 failed to have the identity of the testing person documented. ===================================== -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: ==================================== ALWAYS REFER TO STANDARD TAG IN APPROPRIATE LAB SPECIALTY. Hematology: The laboratory failed to maintain satisfactory participation in two out of two events for the automated white blood cell (WBC) differential, resulting in the first unsuccessful proficiency testing (PT) occurrence for the automated WBC differential analyte (Refer to D2130). ===================================== D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: =================================== Based on a desk review of the CMS CASPER Report 0155D and the laboratory's 2018 Proficiency Testing (PT) records, the laboratory failed to maintain satisfactory performance for the automated WBC (White Blood Cell) Differential in the 2nd and 3rd events of 2018, resulting in the first unsuccessful occurrence. The findings include: 1. Review of the CMS 0155D report revealed the 2018 automated WBC Differential events two and three scores were 0%. 2. Review of the laboratory's 2018 PT records revealed event two had an unacceptable score of 0% for the WBC Auto Differential. 3. Review of the laboratory's 2018 PT records revealed event three had an unacceptable score of 0% for the WBC Auto Differential, resulting in the first unsuccessful PT occurrence. ==================================== -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --